Human Immunodeficiency Virus
Conditions
Keywords
Injection site reactions, enfuvirtide administration
Brief summary
Hypothesis: Patients using enfuvirtide with the Biojector have an improved quality of life, greater satisfaction, and fewer adverse events compared with using the standard needle.
Detailed description
This study is a N of one trial where the patient is their own control. We will provide the quality of life questionnaire, the MOS-HIV questionnaire; ISR questionnaire and a satisfaction questionnaire to patients that have used a standard need to inject enfuvirtide for at least one month. As well, demographics and laboratory data will be collected. The same procedures will be given 1 month after the use of Biojector in a follow-up visit.
Interventions
DEVICEBiojector
All patients received biojector to use with BID enfuvirtide doses
Sponsors
Roche Pharma AG
Canadian Immunodeficiency Research Collaborative
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
Patients who have taken enfuvirtide for at least one month
Exclusion criteria
Patients with hemophilia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To compare quality of life, satisfaction, and adverse events in patients using a Biojector® versus using a standard needle system for administration of enfuvirtide. | 1 month | To compare quality of life, satisfaction, and adverse events in patients using a Biojector® versus using a standard needle system for administration of enfuvirtide. |
Countries
Canada
Outcome results
None listed